Dr. Jack Wazen is an otolaryngologist in Sarasota at the First Physicians Group. He has more than four decades of experience. I interviewed him in 2019 on the topic of cochlear implantation for this website.

The current hot-button topic is Over the Counter (OTC) hearing aid. They were recently approved by FDA for sale in pharmacies and other outlets. These devices are designed for mild to moderate hearing loss and expected to expand the availability of hearing devices at a lower price than prescription.

They may be purchased without a professional hearing evaluation. Is obtaining a hearing aid without a medical exam be good or bad for the public? Is a lower price necessarily the only consideration for a person with a hearing loss?

I was glad that Dr. Wazen was able to sit down with me an opine on this issue and other aspects of OTC hearing aids.

Transcript

Voiceover:

Cochlear Implant Basics is a site for candidates and their families and friends. If you have been told you qualify for a cochlear implant, these podcast interviews tell how receiving a cochlear implant can be a life changing experience. You will meet recipients who face a hearing loss and the hearing aids could no longer provide comprehension of speech or music. They face growing isolation, inability to socialize or compete in the world of business. The joy of music disappeared. They explain how receiving a cochlear implant changed their lives. Welcome to Cochlear Implant Basics. A reminder, Cochlear Implant Basics is not sponsored by anyone, nor is it offering medical advice. Please consult your own healthcare provider.

Richard:

This afternoon, we’re talking with Dr. Jack Wazen. We did an interview about two years ago, I believe, but I need to get some background from you about over the counter hearing aids, because they are a new phenomena. What you see, the history of it happening, how did it happen and what you see for the future of them?

Dr. Jack Wazen:

Well, this is a good question and it’s an important question, because there could be a lot of confusion out there as to who needs what. I think the concept of providing the public with a cheaper hearing device is a sound and important concept, because I don’t think we should accept that people with lesser economical power cannot be left not hearing. Having said that, and I think I’ve said that to you in previous times, cost is not the only reason people do not use hearing aids. Because we know from different studies in countries where hearing aids are being provided for free through their insurance or government insurance and so on, we still see poor hearing aid sales or use, because people don’t want to be seen using a hearing aid or because people are too vain to be…

You just reminded me, I was talking to an 80 year old patient a few years ago. I said, “You need hearing aids.” She said, “I don’t want a hearing aids.” I said, “Why don’t you want a hearing aids?” She says, “Because I don’t want to look old.” So, I said, “Listen, you’re 80 years old, so you are in the age group that requires hearing aids, so accept it.” Forget about the vanity part, but it is still a big factor.

Richard:

What’s a percentage of people in the countries that provide hearing aids? Do you know what percentages of people that get helped by the hearing aid? Is it like 2%, 5%, 20%?

Dr. Jack Wazen:

Well, I think the hearing aid, the use in people who need them is still way less than 50%. There’s still a void between who needs hearing aids and is using hearing aid, versus people who need hearing aid and are not using hearing aid in all countries.

Richard:

No matter whether they’re paid for or not?

Dr. Jack Wazen:

Correct.

Richard:

Do you think that will change in the United States with the over the counter hearing aids? Will more people be getting them?

Dr. Jack Wazen:

I am very optimistic that the availability of the over the counter hearing aid will encourage people to use a device, to see whether using a device to enhance their hearing is enhancing their quality of life. This could take us in two directions. People may use the over the counter hearing aid and find it helpful and use it. And as the hearing declines, because it will over time, the over the counter hearing aid becomes less efficient, less effective. Over the counter hearing aids are for mild to moderate hearing loss. They’re not for the moderate to severe hearing loss. So, if we are servicing the mild to moderate, and then those people who have benefited from better hearing then transfer to the regular prescription kind of hearing aids, then we’ve achieved our goal of providing hearing health to who needs it.

Richard:

And taking it from the other side, suppose somebody needs hearing help gets over the counter hearing aids and it’s not working for them, maybe they’ll just say, “Oh, it’s never going to work.”

Dr. Jack Wazen:

Well, that is the negative side. So, the negative side is they try it and it doesn’t work. It does not mean that hearing aids don’t help. It means that the over the counter hearing aid that you are fitted with is not the right thing for you. It means you ought to look into a better prescription fitted hearing aid, which is customized to your particular need.

Richard:

I’ve gone through Walmart, I’ve studied their over the counter, which they basically give you a QR code, click this, and then contact us for the hearing test over hourly internet. But I noticed they had several different categories of hearing aids, 499, 399, 599, 699. They were selling different categories. I’m still going to be curious how an over the counter buyer is going to decide which one is suitable for them.

Dr. Jack Wazen:

They don’t know. They cannot decide. And one thing I have to say that I do not agree with as far as the fitting of hearing aids, is when the FDA or whatever governmental institution said, “You do not need to see a physician to go and buy yourself hearing aids.” So, they took the medical opinion out of the formula. Now, the medical opinion is the cheapest of the whole thing, and it’s the most important of the whole thing. Because an ear is in organ, if you have a failure of an organ, you need the medical evaluation to diagnose it. Number one, why is it failing? Number two, how much is it failing? Do you need this? Do you need that? What do you need? When your kidneys fail, you could use diuretics initially. You may end up needing dialysis. How do you know? You don’t know.

As a patient, you do not know these things without proper medical evaluation. And I’m afraid that by removing the medical opinion out of this, we’re going to find dissatisfied people. And more worrisome, we’re going to find people who are underdiagnosed of problems that need to be treated. So, not everybody who has a hearing loss just needs a hearing aid.

Richard:

Why do you think the FDA bypassed the medical part? I’m surprised that they did, but your opinion.

Dr. Jack Wazen:

Because of pressure to reduce the cost. They said, okay, if we’re going to reduce the cost, we will eliminate any impeding factor in obtaining hearing aid. The medical opinion was never impeding. And the medical opinion, whether you’re going to pay $50, $100, $150, whatever it is, it’s cheaper than the hearing aid.

Richard:

Political pressure.

Dr. Jack Wazen:

It’s pressure, public pressure. I think the people wanted that.

Richard:

I tried to follow some of the public input that the FDA was getting, and I don’t recall seeing anybody talking about the medical side of it, but I imagine the pressure must have been enormous to do that. My own opinion, it’s not like buying a pair of cheaters off the rack in a drug store, because if it doesn’t work, you put them back. The hearing aid you have to take out and try.

Dr. Jack Wazen:

Since you are comparing it to the eyes, if you have a cataract, you could go and buy the best cheaters you can, you’re not going to see better. You need a diagnosis. First step in any medical condition, and hearing loss is a medical condition, is what is the diagnosis, what is the level of failure and what is the most appropriate way to do it? In mild to moderate hearing loss, go and get the OTC hearing aid. The companies who are making them are very strong audio file kind of companies. If I buy anything from Bose, I know I’m going to have great product. If I buy anything from Apple, I’m going to have a great product. So, the quality of the tool, of the instrument is not the issue here, because I know you’re going to get a good product. The question is, is that the right product for your level of hearing? And if we are not evaluating you medically, then it becomes a matter of trial and error of you trying the 399 or the 499 or the 699 and see what works for you.

Richard:

Occurring to me too, that we’re in the State of Florida and the State of Florida under statute requires the audiologist or the hearing aid dispenser to talk about the hearing loop. But there are no hearing loops built into these OTCs as far as I know. And I’m wondering now whether the State of Florida gave an exemption for it.

Dr. Jack Wazen:

The OTC is not a medical device and doesn’t fall under the same scrutiny as a medical device like a hearing aid does. So, it’s an entry level device for people with mild hearing loss. I sat on the board of the Hearing Loss Association for many years, and I’ve heard the pros and the cons. And I’ve heard the pros and the cons from the American Academy of Otolaryngology who was initially against that. It was against removing the medical opinion and it was against the OTC, but then we all accepted it as a matter of fact. Let’s look at the positive side of things. Let’s say if this is available and this is going to open people’s mind and acceptance of wearing a hearing device, then maybe we could get them back into the loop of proper hearing and better hearing if and when they need it.

Richard:

It still intrigues me that people get an annual physical, but they don’t get an annual hearing test. Now, I’ve mentored hundreds and hundreds of people, and my experience is that a person with a hearing loss can’t possibly know what they’re missing. And I don’t really see an exception in this case. Somebody says, “Oh, I have mild hearing loss,” how can you know?

Dr. Jack Wazen:

They don’t know. And that’s an argument that we have with lots of people. I mean, we see people, senior citizens here, hundreds and hundreds per week. And you have those who acknowledge that they have hearing loss, and we have those whose family brings them in. Wife, spouse say, “He can’t hear.” But we have a lot of people who say, “I can’t hear.” And the counter-argument is that, but you don’t know what you’re missing, because if you do not hear it, it doesn’t mean that it’s not there. So, sometimes the judgment of hearing loss comes from the surrounding people, rather than the person themselves. They’re very astute about their ability to communicate with people.

Richard:

Which is not too many people fall into that category.

Dr. Jack Wazen:

That is true.

Richard:

My question now is we’ve discussed the pros and cons. The best case is you’ve mentioned is that they will get to professional help at some point. What’s the worst case?

Dr. Jack Wazen:

The worst case is that we are missing ear disease. We are missing a cholesteatoma. This is a disease of the ear that destroys the hearing mechanism. We are missing an acoustic neuroma. We are missing a meniere condition. I mean, there are medical condition that cause hearing loss. When you say we’re going to start with the hearing aid, you’re putting the cart in front of the horse. So, make a diagnosis, determine that the hearing aid is the right option, and then prescribe the hearing aid. And if it’s a mild to moderate hearing loss, then we would prescribe the over the counter hearing aid. We have no problem with that. And if it’s more of a moderate to severe hearing loss, we would recommend save your money, don’t go waste it on the OTC. You need a more formalized fitting because that’s what you need.

Richard:

This is the message I hope that my listeners take to heart, that OTC is not the answer to everything, and you still should be getting a hearing evaluation before you go out and buy an OTC.

Dr. Jack Wazen:

I totally agree.

Richard:

Did you have anything you’d like to add before we close?

Dr. Jack Wazen:

I think we’ve covered so much. But if your audience comes back to you with questions that we need to clarify, I’ll be happy to sit down with you again.

Richard:

Thank you so much. We’ve been talking to Dr. Jack Wazen and I appreciate your time and your insights.

Dr. Jack Wazen:

You’re welcome.